The following data is part of a premarket notification filed by Visage Imaging Gmbh with the FDA for Visage Ease Pro.
| Device ID | K142196 |
| 510k Number | K142196 |
| Device Name: | Visage Ease Pro |
| Classification | System, Image Processing, Radiological |
| Applicant | VISAGE IMAGING GMBH LEPSIUSTRASSE 70 Berlin, DE 12163 |
| Contact | Stefan Strowich |
| Correspondent | Stefan Strowich VISAGE IMAGING GMBH LEPSIUSTRASSE 70 Berlin, DE 12163 |
| Product Code | LLZ |
| CFR Regulation Number | 892.2050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-08-11 |
| Decision Date | 2015-04-28 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04251332920016 | K142196 | 000 |
| 04251332920009 | K142196 | 000 |
| 04251332920023 | K142196 | 000 |
| 04251332920030 | K142196 | 000 |
| 04251332920047 | K142196 | 000 |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() VISAGE EASE PRO 87036252 5122442 Live/Registered |
PME IP Pty Ltd 2016-05-13 |
![]() VISAGE EASE PRO 86857980 5189117 Live/Registered |
PME IP Pty Ltd 2015-12-27 |
![]() VISAGE EASE PRO 86631759 5151841 Live/Registered |
PME IP PTY LTD 2015-05-15 |